SIMVASTATIN TABLETS

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

SIMVASTATIN

Tilgjengelig fra:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-kode:

C10AA01

INN (International Name):

SIMVASTATIN

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

SIMVASTATIN 10MG

Administreringsrute:

ORAL

Enheter i pakken:

21/30/1000

Resept typen:

Prescription

Terapeutisk område:

HMG-COA REDUCTASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0122415004; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2009-08-13

Preparatomtale

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_Page 1 of 45_
PRODUCT MONOGRAPH
SIMVASTATIN TABLETS
(SIMVASTATIN)
USP
5 MG, 10 MG, 20 MG, 40 MG AND 80 MG
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 21,
2009
2680 Matheson Blvd. East, Suite 200
Mississauga, ON L4W 0A5
Canada
SUBMISSION CONTROL NO: 131952
_ _
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
......................................................................3
INDICATIONS AND CLINICAL
USE.............................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND
PRECAUTIONS.................................................................................5
ADVERSE
REACTIONS..................................................................................................12
DRUG
INTERACTIONS..................................................................................................14
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
...............................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
...........................................................19
STORAGE AND
STABILITY.........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................19
PART II: SCIENTIFIC
INFORMATION................................................................................21
PHARMACEUTICAL
INFORMATION.........................................................................21
CLINICAL
TRIALS.........................................................................................................22
DETAILED
PHARMACOLOGY................................................